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ELIQUIS Drug Profile

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Eliquis is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug.

This drug has one hundred and eleven patent family members in forty countries.

The generic ingredient in ELIQUIS is apixaban. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apixaban profile page.

Summary for Tradename: ELIQUIS

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: ELIQUIS

Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors

Clinical Trials for: ELIQUIS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYes<disabled><disabled>
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYes<disabled><disabled>
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-001Dec 28, 2012RXNo6,413,980<disabled>YY <disabled>
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Non-Orange Book Patents for Tradename: ELIQUIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,995,172Lactam-containing compounds and derivatives thereof as factor Xa inhibitors<disabled in preview>
8,470,854Lactam-containing compounds and derivatives thereof as factor XA inhibitors<disabled in preview>
6,673,810 Imidazo-heterobicycles as factor Xa inhibitors<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ELIQUIS

Country Document Number Estimated Expiration
Poland373299<disabled in preview>
Spain2232202<disabled in preview>
Denmark2538925<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ELIQUIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0110017 00045Estonia<disabled>PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011
11/032Ireland<disabled>PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415/01Switzerland<disabled>PRODUCT NAME: APIXABAN; REGISTRATION NO/DATE: SWISSMEDIC 61549 26.08.2011
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